Last updated: 10/17/2025 06:20:10

A Study to Evaluate the Real-World Effectiveness of Mepolizumab in Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in Japan

GSK study ID
224088
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: J REALITI-N: An Observational Study to Evaluate the Real-World Effectiveness of Mepolizumab in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in Japan
Trial description: The aim of this observational study is to evaluate the effectiveness of mepolizumab in Japanese participants with CRSwNP, who are newly prescribed mepolizumab, in real-world practice. Baseline will be defined as the closest measure that will be taken in the 45 days before mepolizumab initiation. Index date (Day 1) will be defined as mepolizumab initiation date, and the 12-month follow-up will be defined as 12 months after mepolizumab initiation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change from Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Total Score

Timeframe: Baseline to Month 12

Secondary outcomes:

Change from Baseline in SNOT-22 Total Score

Timeframe: Baseline, Month 3, and Month 6

Change from Baseline in Visual Analogue Scale (VAS) Score for Smell Dysfunction and Nasal Obstruction

Timeframe: Baseline, Month 3, Month 6, and Month 12

Percentage of Participants who Experienced CRSwNP-related Exacerbations

Timeframe: Baseline, Month 3, Month 6, and Month 12

Incidence Rate of CRSwNP Exacerbations at Months 3, 6, and 12

Timeframe: Baseline, Month 3, Month 6, and Month 12

Time to First Exacerbation

Timeframe: Baseline, Month 3, Month 6, and Month 12

Change from Baseline in Nasal Polyp (NP) Score Per Nasal Endoscopy

Timeframe: Baseline to Month 12

Number of NP Surgeries

Timeframe: Baseline, Month 3, Month 6, Month 12

Percentage of Participants who Underwent NP-related Surgery

Timeframe: Baseline, Month 3, Month 6, and Month 12

Incidence Rate of NP Surgeries at Months 3, 6, and 12

Timeframe: Baseline, Month 3, Month 6, Month 12

Percentage of Participants who Underwent Polypectomy, Full House, Reboot, or Draft III Surgeries

Timeframe: Baseline, Month 3, Month 6, and Month 12

Time to First NP Surgery

Timeframe: Baseline, Month 3, Month 6, and Month 12

Change from Baseline in OCS Use

Timeframe: Baseline, Month 3, Month 6, and Month 12

Mean Percentage Reduction in OCS Dose Utilization from Baseline

Timeframe: Baseline, Month 3, Month 6, and Month 12

Percentage of Participants Achieving Reduction and Cessation in OCS Use Compared to Baseline

Timeframe: Baseline, Month 3, Month 6, and Month 12

Annualized Rate of CRSwNP-related Healthcare Resource Utilization (HCRU)

Timeframe: 12 months before Baseline up to 12 months after mepolizumab initiation

Change from Baseline in Work Productivity and Activity Impairment – General Health (WPAI-GH) Score

Timeframe: Baseline, Month 3, Month 6, and Month 12

Change in Mepolizumab Dosing

Timeframe: Baseline, Month 3, Month 6, and Month 12

Change in Frequency of Mepolizumab Utilization

Timeframe: Baseline, Month 3, Month 6, and Month 12

Percentage of Participants with Treatment Interruptions

Timeframe: From Baseline up to Month 12

Percentage of Participants with Treatment Cessation

Timeframe: From Baseline up to Month 12

Time to Mepolizumab Cessation

Timeframe: From Baseline up to Month 12

Percentage of Participants Using Concomitant Medications

Timeframe: From Baseline up to Month 12

Change in Concomitant Medication Use

Timeframe: From Baseline up to Month 12

Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2027-27-07
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Nasal Polyps
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
October 2025 to July 2027
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Greater than or equal to (>=) 18 years of age at initiation of mepolizumab.
  • Participants with an investigator’s main diagnosis of CRSwNP confirmed by clinical criteria (including any imaging if performed) where CRSwNP is the main diagnosis indicated for use of mepolizumab per Japanese labelling requirements.
  • Participation in an interventional study that includes treatment with an investigational drug and/or treatment for CRSwNP at the same time as the index date (mepolizumab initiation).
  • Prior participation in an interventional study that includes treatment with mepolizumab.
Inclusion and exclusion criteria
Inclusion criteria:
  • Greater than or equal to (>=) 18 years of age at initiation of mepolizumab.
  • Participants with an investigator’s main diagnosis of CRSwNP confirmed by clinical criteria (including any imaging if performed) where CRSwNP is the main diagnosis indicated for use of mepolizumab per Japanese labelling requirements.
  • Mepolizumab initiation is defined as: Physician’s decision to prescribe mepolizumab for treatment of CRSwNP; participant treatment-naïve at time of study enrolment.
  • Participants must be willing and able to provide voluntary informed consent.
  • Participants must be able to understand and complete study-related questionnaires.
  • Participants must have access to a compatible device and internet access for electronic patient-reported outcome (ePRO) completion and be willing and able to comply with ePRO data collection.
Exclusion criteria:
  • Participation in an interventional study that includes treatment with an investigational drug and/or treatment for CRSwNP at the same time as the index date (mepolizumab initiation).
  • Prior participation in an interventional study that includes treatment with mepolizumab.
  • Diagnosis of eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, cystic fibrosis, immunodeficiency, and primary ciliary dyskinesia, or any other condition that would make it difficult for the participant to fulfil the study criteria, per the investigator’s discretion.
  • Prior use of another respiratory biologic (including but not limited to omalizumab, dupilumab, tezepelumab, or benralizumab) within six months of mepolizumab index date.
  • Use of concomitant therapy with another respiratory biologic at the time of mepolizumab treatment.
  • Three or more functional endoscopic sinus surgery (FESS) which includes anterior maxillectomy and/or ethmoidectomy and/or sphenoidotomy, or three or more ESS with or without DRAF IIB or DRAF III.
  • Pregnant or breastfeeding at the mepolizumab initiation (note: participants who become pregnant during the study will not be excluded, provided they consent to continue with mepolizumab).

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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